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  5. Label Information: Bal-care Dha Essential

FDA Label for Bal-care Dha Essential

View Indications, Usage & Precautions

Table of Contents

    1. DESCRIPTION
    2. INSTRUCTIONS FOR USE
    3. WARNINGS AND PRECAUTIONS
    4. STORAGE AND HANDLING

Bal-care Dha Essential Product Label

The following document was submitted to the FDA by the labeler of this product Prugen, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Description



SUPPLEMENT FACTS
Serving Size 1 Tablet:
VITAMINS
A (beta carotene)  . . . . . . . . . . . . . . . . . . . . . . . . . . 2,850 IU    36% Daily Value
C (ascorbic acid)    . . . . . . . . . . . . . . . . . . . . . . . . . . 120 mg    200% Daily Value
D (cholecalciferol)    . . . . . . . . . . . . . . . . . . . . . . . . .840 IU    210% Daily Value
E (dl-alpha tocopheryl acetate)  . . . . . . . . . . . . . .3 mg    10% Daily Value
B1 (thiamine mononitrate)  . . . . . . . . . . . . . . . . . . .1.8 mg    106% Daily Value
B2 (riboflavin)   . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4 mg    200% Daily Value
Niacinamide   . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 mg    100% Daily Value
B6 (pyridoxine hydrochloride)  . . . . . . . . . . . . . . .50 mg    2000% Daily Value
Folic acid    . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1 mg    125% Daily Value
B12 (cyanocobalamin)   . . . . . . . . . . . . . . . . . . . . . . 12 mcg    150% Daily Value
 
MINERALS
Calcium (calcium carbonate)  . . . . . . . . . . . . . . . . 219 mg    17% Daily Value
Iron (as sodium iron EDTA and polysaccharide iron complex) . . .27 mg    150% Daily Value
Magnesium (magnesium oxide)  . . . . . . . . . . . . . 25 mg    6% Daily Value
Zinc (zinc oxide)  . . . . . . . . . . . . . . . . . . . . . . . . .  . . . 25 mg    167% Daily Value
Copper (cupric oxide)  . . . . . . . . . . . . . . . . . . . . . . . .2 mg    100% Daily Value

Service Size 1 Softgel:
374 mg purified omega-3 fatty acids including:
At least 262 mg DHA (docosahexaenoic acid); also contains at least 112 mg of other omega-3 fatty acids.

OTHER TABLET INGREDIENTS:
Microcrystalline Cellulose, Hydroxypropyl Methylcellulose, Crospovidone, Maltodextrin, Acacia Gum, Silicon Dioxide, Triacetin, Magnesium Stearate, Titanium Dioxide, Polydextrose, Yellow #6 Lake, Blue #2 Lake, Red #40 Lake.

OTHER SOFTGEL INGREDIENTS:
Ammonium Hydroxide, Ethylcellulose, Gelatin, Glycerin, Medium Chain Triglycerides, Oleic Acid, Sodium Alginate, Stearic Acid, Vanillin.
Softgel contains fish and soybeans





Instructions For Use



Directions:  
Before, during and after pregnancy, one tablet and one enteric-coated softgel capsule taken by mouth daily, or as directed by a physician.

Use:  To provide vitamin and mineral supplementation throughout pregnancy and during the postnatal period for both the lactating and non lactating mother. It is also useful for improving nutritional status prior to conception.


 


Warnings And Precautions



WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.

Warnings:  Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B12 is deficient.

Precautions:  Folic acid especially in doses above 1.0 mg daily may obscure pernicious anemia (hematologic remission may occur while neurological manifestations remain progressive). Caution should be exercised to ensure that the prescribed dose of DHA does not exceed 1 gram (1,000 mg) per day. Since daily ingestion of more than 3 grams (3,000 mg) per day of omega-3 fatty acids (including alphalinolenic acid (ALA), eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)) from fish oils may have potential antithrombotic activities and may increase bleeding times, administration of DHA should be avoided in patients with inherited or acquired bleeding diatheses, including those taking anticoagulants.


Storage And Handling



Store at room temperature

Keep out of reach of children


Manufactured for:

PruGen inc. Pharmaceuticals

8714 E Vista Bonita Dr

Scottsdale, AZ 85255


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